[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-cell-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-cell-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,51,94,118,143,180,212,242,273,300,324,366,393,429,448,471,496],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100272786","phase-1-administering-peripheral-blood-lymphocytes-transduced-with-a-cd70-binding-chimeric-antigen-receptor-to-people-with-cd70-expressing-cancers-100272786",false,"NCT02830724","Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers","A Phase I\u002FII Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers","* INCLUSION CRITERIA:\n* For Phase I: Evaluable, unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* For Phase II: Measurable (per RECIST v1.1 criteria), unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.\n* Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred.\n* Patients with 3 or fewer brain metastases that are less than or equal to 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for women and for four months after treatment for men.\n* Women of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n-Serology\n\n--Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental\n\ntreatment and more susceptible to its toxicities.)\n\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  -Hematology\n* ANC greater than 1000\u002Fmm(3) without the support of filgrastim\n* WBC greater than or equal to 2500\u002Fmm(3)\n* Platelet count greater than or equal to 80,000\u002Fmm(3)\n* Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n\n  -Chemistry\n* Serum ALT\u002FAST less than or equal to 5.0 times ULN\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL.\n\n  * Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on the NCI-SB cell harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).\n\nEXCLUSION CRITERIA:\n\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n* History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities).\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Patients who are receiving any other investigational agents.","ALL","18 Years","72 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nIn a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70.\n\nObjectives:\n\nTo see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe.\n\nEligibility:\n\nAdults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.\n\nEligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital.\n\nParticipants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis.\n\nParticipants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam.\n\nThroughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.",[28,29,30,31,32],"Pancreatic Cancer","Renal Cell Cancer","Breast Cancer","Melanoma","Ovarian Cancer",[34,29,35,36,37],"Metastatic Solid Cancers","Cell Therapy","CAR T-Cells","Immunotherapy","RECRUITING","2026-06-12",{"date":41,"type":42},"2026-06-15","ACTUAL",{"date":44,"type":42},"2017-04-06",{"date":46,"type":21},"2030-01-01",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":79,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":59,"type":21},126,[24,25],"This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[63,64,31,65,66,67,68,69,70,71,72,29,73,74,75,76,77,78],"Advanced Cancer","Advanced Solid Tumor","Metastasis","Pleural Mesothelioma","Renal Cell Carcinoma","MSI-High","Mismatch Repair Deficiency","Colorectal Cancer","Hepatocellular Carcinoma","Hepatocellular Cancer","Kidney Cancer","Skin Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[80,81,82],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":85,"type":42},"2026-04-13",{"date":87,"type":42},"2024-08-23",{"date":89,"type":21},"2028-12-31",{"name":91,"class":92},"7 Hills Pharma, LLC","INDUSTRY",5,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":50},"100630958","phase-2-phase-2-study-of-wgi-0301-plus-nivolumab-in-patients-with-hcc-and-rcc-100630958","NCT07494435","Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC","An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma","Inclusion Criteria:\n\n* 1\\) Age 18-75 (inclusive) on the day of singing informed consent, male or female.\n\n  2\\) Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol 3) Subjects in each disease cohorts will need to fulfill the following criteria:\n\n  • HCC Cohort:\n  1. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria\n  2. 4\\. Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not suitable for any curative surgeries or locoregional therapy\n  3. Child-Pugh Liver Function Class A or Class B (score ≤ 7)\n  4. Documented first-line standard treatment failure (disease progression or intolerance)；\n\n     * nccRCC Cohort：Histologically or cytologically confirmed diagnosis of nccRCC，that is locally advanced or with distant metastasis, and have not received any prior systemic antitumor therapy. If disease progression occurs within 6 months after the last dose of adjuvant therapy, it is considered a failure of first-line treatment and thus does not meet the criteria.\n     * ccRCC Cohort：Histologically or cytologically confirmed ccRCC, with locally advanced unresectable disease or distant metastasis, and disease progression or intolerance after prior first-line therapy. Patients who have received adjuvant or neoadjuvant therapy may also be screened if they meet the above criteria.\n\n       4\\) Eligible for treatment with Nivolumab as determined by investigators according to the Package Insert and clinical judgment.\n\n       5\\) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention 6) Life expectancy in the judgement of the Investigator \\> 12 weeks. 7) Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy such as radiotherapy; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.\n\n       8\\) Any adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤ Grade 1 (CTCAE v6.0). However, patients may still be screened if the investigator determines that the toxicity is well-controlled and does not affect the patient's safety or compliance with the study drug, and this has been confirmed with the sponsor.\n\n       9\\) Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.\n\n       10\\) Patients must have adequate organ function as defined below:\n     * For patients with no liver metastasis or lesion: AST and ALT ≤2.0× ULN, and total bilirubin ≤1.5×ULN; For patients with liver metastasis or lesion: AST and ALT ≤3.0× ULN, and total bilirubin ≤2×ULN; For patients with Gilbert Syndrome: Total bilirubin ≤3×ULN\n     * Serum albumin≥30g\u002FL\n     * Creatinine Clearance (CrCL) ≥50 mL\u002Fmin (Cockcroft-Gault formula: Ccr=(140-Age)×body weight (Kg)\u002F72×Scr（mg\u002Fdl）{×0.85 for female subject}\n     * International Normalized Ratio (INR) ≤2.0 (except for patients on warfarin therapy)\n     * Hemeglobin≥90g\u002FL, ANC ≥1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days) 11) Participants with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be allowed if they meet the following criteria:\n     * HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \\\u003C 500 IU\u002F mL, and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for \\>2 weeks before the first dose\n     * HCV-HCC: • HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded 12) Women of child-bearing potential (WOCBP) must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration.\n\n     Exclusion Criteria:\n* 1\\) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria：\n\n  * Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).\n  * Fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma or mixed hepatocellular cholangiocarcinoma；\n  * 3\\. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) 3) Major surgery within 4 weeks prior to the first dose of study intervention. 4) Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials) 5) Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose 6) Received systemic corticosteroid (prednisone \\>10mg\u002Fday or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study intervention. Inhale or local corticosteroid, or pre-medications for infusion-related reactions\u002F hypersensitivity is allowed.\n\n    7\\) Received live vaccines and live attenuated vaccines within 4 weeks prior to the first dose of study treatment, or expected to received live vaccinve or live attenuated vaccine while participating in the study 8) Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs, or Nivolumab or related excipients 9) Prior treatment with agents targeting the PI3K-AKT pathway 10) 13. Clinically significant cardiovascular disease including:\n  * Uncontrolled chronic hypertension defined as systolic \\> 150 mmHg or diastolic \\> 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is \\\u003C 150\u002F 90 mmHg)\n  * Hypotension as indicated by systolic blood pressure \\\u003C 90 mmHg or mean arterial pressure \\\u003C 65 mmHg on 2 consecutive measurements at the Screening Visit\n  * NYHA class III or IV Congestive heart failure, stroke, transient ischemic attack, pulmonary embolism, myocardial infarction, unstable angina pectoris, or left ventricular ejection fraction \\\u003C 50% within 6 months prior to the first dose.\n  * Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy)\n  * Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate \\\u003C 50 bpm), or screening ECG indicating QTcF \\> 470 msec, 2 retests are required for the first abnormal QTcF , and the mean value should be taken from the 3 readings. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.\n\n    11\\) Clinically significant bleeding risks including:\n  * Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)\n  * History of bleeding symptoms due to esophageal or gastric varices within 6 months prior to the first dose\n  * Received thrombolytic agents within 10 days prior to the first dose, or currently receiving anticoagulant therapy (e.g. anticoagulant, antiplatelet) and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency) 12) Known HIV or AIDS related illness, or history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant 13) Patients with endocrine disorders that cannot be effectively controlled by hormone replacement therapy 14) Presence of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, including but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, etc. However, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency managed with hormone replacement therapy only; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); or conditions not expected to recur in the absence of external triggers are allowed.\n\n    15\\) History of gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to the first dose 16) Skin ulcers or severe, non-healing, or dehisced wounds within 3 months prior to the first dose 17) Known active or uncontrolled infection that may interfere with the study (e.g., active infection requiring intravenous antibiotic therapy or unexplained fever \\>38.5°C) 18) History of interstitial lung disease or prior non-infectious pneumonitis requiring corticosteroid treatment, or imaging findings suggestive of active pneumonia 19) History of other malignancies prior to or at study entry (except for adequately treated carcinoma in situ of the cervix, basal cell and squamous cell skin cancer, or other malignancies that have undergone curative treatment with no evidence of disease for at least 3 years).\n\n    20\\) Pleural effusion, ascites, or pericardial effusion that are clinically symptomatic or requiring repeated drainage (as judged by the investigator) 21) Known symptomatic or untreated brain metastases, leptomeningeal metastases, or other central nervous system metastases (except for asymptomatic cases not requiring treatment).\n\n    22\\) History of drug abuse or addiction 23) Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data","75 Years",{"count":103,"type":21},230,[25],"This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.",[107,29],"Hepato Cellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-03-19",{"date":111,"type":42},"2026-03-27",{"date":113,"type":21},"2026-06-01",{"date":115,"type":21},"2028-09-01",{"name":117,"class":92},"Zhejiang Haichang Biotech Co., Ltd.",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":50},"100615611","contrast-enhanced-ultrasound-and-super-resolution-imaging-predict-renal-function-outcome-after-nephrectomy-100615611","NCT07294859","Contrast-enhanced Ultrasound and Super-resolution Imaging Predict Renal Function Outcome After Nephrectomy","A Prospective Clinical Study on the Predictive Value of CEUS and Super-resolution Imaging Technology for Renal Function Outcome in Patients After Partial or Radical Nephrectomy","Inclusion Criteria:\n\n* Fully understood and voluntarily signed the informed Consent Form (ICF);\n* Age: \\> 18 (at the time of signing the informed consent form); Gender is not limited.\n* Preoperative eGFR \\> 45ml\u002Fmin\u002F1.73m2 (corrected CKD-EPI formula);\n* After the clinician formulates the treatment plan and communicates with the patient, they decide whether to perform radical nephrectomy or partial nephrectomy.\n* ECOG score: 0-2 points;\n* Be willing and able to abide by the visits, treatments, laboratory tests and other procedures of the research plan.\n\nExclusion Criteria:\n\n* Patients with solitary kidney or severe contralateral renal insufficiency (eGFR \\\u003C 15ml\u002Fmin\u002F1.73m2);\n* Preoperative reliance on renal replacement therapy (such as dialysis, etc.);\n* Those who fail to complete the nephrectomy as planned during the operation;\n* Patients with lymph node metastasis, distant metastasis or venous tumor thrombus;\n* The healthy kidney has undergone radiotherapy, ablation or other surgeries.\n* Have a history of allergy to ultrasound contrast agents;\n* Have any contraindications for contrast-enhanced ultrasound, such as right-to-left shunt, severe pulmonary hypertension, etc.\n* Patients with hemodynamic instability, including those with persistent hypotension (blood pressure \\\u003C 90\u002F60 MMHG), uncontrollable heart failure, active bleeding (such as gastrointestinal and cerebral hemorrhage, etc.), or those with a bleeding tendency and hemoglobin \\\u003C 60g\u002FL and\u002For platelet count \\\u003C 50×109\u002FL;\n* Accompanied by structural abnormalities of the urinary system or functional abnormalities that cannot be corrected in a short time (such as duplicate kidneys, polycystic kidneys, horseshoe kidneys, isolated kidneys, renal artery stenosis \\> 50%, urinary tract obstruction, and previous history of kidney surgery, etc.), long-term indwelling of urinary catheters, etc.\n* There are other diseases that limit life expectancy to less than six months;\n* Previous (≤30 days before randomization) or concurrent participation in another clinical study.",{"count":126,"type":21},285,"12 Months","OBSERVATIONAL","The goal of this prospective cohort study is to evaluate the predictive value of Contrast-Enhanced Ultrasound (CEUS) and Super-Resolution Imaging (SRI) technologies regarding renal function outcomes in patients with renal cell carcinoma (RCC) undergoing partial or radical nephrectomy. The main questions it aims to answer are:\n\nCan quantitative parameters of renal microcirculation and microvascular structure derived from CEUS and SRI predict long-term renal function (defined as New Baseline eGFR for radical nephrectomy and Recovery from Ischemia for partial nephrectomy)? Can these imaging parameters accurately predict the occurrence, severity, and early recovery of postoperative acute kidney injury (AKI)? Researchers will monitor the dynamic evolution of renal blood flow and microvascular density by comparing the affected kidney to the contralateral healthy kidney before and after surgery to see if these biomarkers correlate with clinical outcomes.\n\nParticipants will:\n\nUndergo CEUS and SRI examinations before surgery and at specific time points after surgery (e.g., within 7 days) to visualize renal microvasculature.\n\nProvide blood and urine samples for standard laboratory tests (such as serum creatinine and Cystatin C) to assess kidney function during hospitalization.\n\nAttend follow-up visits at 1, 3, 6, 9, and 12 months post-surgery to monitor long-term renal recovery and complete necessary imaging assessments (CT or Ultrasound).",[131,29,132],"Nephrectomy","AKI - Acute Kidney Injury","2025-12-08",{"date":135,"type":42},"2025-12-19",{"date":137,"type":42},"2025-09-01",{"date":139,"type":21},"2027-12-01",{"name":141,"class":142},"Jinling Hospital, China","OTHER",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":151,"targetDuration":153,"studyType":128,"phases":4,"briefSummary":154,"conditions":155,"keywords":168,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":50},"100568077","vorolanib-in-the-second-line-treatment-of-patients-with-unresectable-or-metastatic-renal-cell-carcinoma-100568077","NCT06676527","Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects have fully understood and voluntarily signed the informed consent form (ICF);\n* 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1;\n* Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components;\n* According to RECIST (version 1.1), there are targets that are considered to be observable;\n* The main organs function well.\n\nExclusion Criteria:\n\n* A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);\n* Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy within 4 weeks prior to the initial study;\n* Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery;\n* A history of severe drug allergy, including but not limited to antibody drugs;\n* Patients with contraindications for immunotherapy restart;\n* A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation may require long-term adrenal corticosteroid therapy. Patients with thyroid, suprarenal, or hypopituitarism that can be controlled by hormone replacement therapy alone, type 1 diabetes mellitus, and psoriasis or vitiligo that do not require systemic treatment are eligible to participate in this study;\n* Toxicity did not resolve after previous antitumor therapy, i.e., regression to baseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion\u002Fexclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the study;\n* Have central nervous system metastases and\u002For cancerous meningitis;\n* Known history of clinically significant liver disease, including those infected with viral hepatitis activity;\n* Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage could be included);\n* Patients with any severe and\u002For uncontrolled disease;\n* Renal failure requires hemodialysis or peritoneal dialysis;\n* Have or have a suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;\n* History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period;\n* Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;\n* Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with study participation or that may interfere with the interpretation of the study results.","80 Years",{"count":152,"type":21},39,"12 Weeks","This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.",[156,157,158,159,160,161,162,163,164,165,29,166,167],"Neoplasms","Kidney Neoplasms","Urologic Neoplasms","Urogenital Neoplasms","Female Urogenital Diseases","Male Urogenital Diseases","Urogenital Diseases","Kidney Diseases","Urologic Diseases","Carcinoma","Carcinoma, Renal Cell","Antineoplastic Agents",[169,170,171],"observational study","clear cell Renal Cell Carcinoma","TKIs","2025-12-04",{"date":174,"type":42},"2025-12-05",{"date":176,"type":42},"2024-09-01",{"date":178,"type":21},"2026-09-01",{"name":141,"class":142},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100587874","phase-4-cabozantinib-and-nivolumab-among-older-patients-with-renal-cell-carcinoma-100587874","NCT06934057","Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma","Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation","CABOLD","Inclusion Criteria:\n\n1. Patients ≥ 70 years-old\n2. Confirmed advanced or metastatic renal-cell carcinoma\n3. Patients not previously treated in metastatic setting\n4. Performance Status 0 to 2\n5. Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.\n6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n7. Patients must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)\n2. Performance Status \\> 2\n3. Any condition that represent a contraindication to Cabozantinib and\u002For Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant\u002Fmodulator (thyroid or adrenal disorder are not an exclusion criteria)\n4. Any severe cardiovascular or thrombo-embolic event in the last three months\n5. Any situation for which exclusive palliative care intervention is recommended\n6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent","70 Years",{"count":190,"type":21},50,[192],"PHASE4","The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer",[73,29],[196,197,198,199,200,201],"renal cell carcinoma","kidney cancer","cabozantinib","nivolumab","elderly patients","geriatric population","2025-09-23",{"date":204,"type":42},"2025-09-24",{"date":206,"type":42},"2025-05-16",{"date":208,"type":21},"2028-04",{"name":210,"class":142},"Gustave Roussy, Cancer Campus, Grand Paris",7,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100464579","phase-1-modi-1-moditope-in-breast-head-and-neck-ovarian-or-renal-cancer-100464579","NCT05329532","Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer","A Phase 1\u002F2, Multicentre, Open-Label Study of Modi-1 Moditope in Patients With Breast, Head and Neck, Ovarian, or Renal Cancer","ModiFY","INCLUSION CRITERIA\n\n1. Patient either has one of the following histologically or cytologically confirmed advanced cancers not amenable to curative intent surgical resection:\n\n   * TNBC\n   * SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)\n   * HGSOC including fallopian tube and primary peritoneal cancers\n   * RCC Or the patient has histologically or cytologically confirmed SCCHN scheduled to have curative intent surgical resection.\n2. Patient must meet one of the following specific criteria for prior treatment of the relevant tumour type:\n\n   * TNBC:\n\n     * patient has received available standard therapy for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a systemic treatment regimen with immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     * patient has received first-line platinum-containing chemotherapy (with or without radiotherapy) as treatment for advanced disease (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient with locally advanced or metastatic disease measurable by RECIST 1.1 for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Modi-1ev\u002FModi-1eKv monotherapy and Modi-1ev\u002FModi-1eKv + CPI cohorts).\n     * patient completing immunotherapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient stopped immunotherapy due to toxicity or completion of immunotherapy but with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient with untreated metastatic or unresectable recurrent SCCHN whose tumours express PD-L1 with a combined positive score (CPS) of one or more and are eligible for SOC immunotherapy (Modi-1ev\u002FModi-1eKv + CPI cohort only). Patients who received their first dose of CPI therapy within 28 days of the first dose of Modi-1ev\u002FModi-1eKv are eligible.\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * SCCHN:\n\n     o neoadjuvant expansion cohort only; patients who are treatment-naïve and are scheduled to have tumour resection surgery, in whom minimum of 3 weeks of Modi-1ev\u002FModi-1eKv and a single 400 mg intravenous (i.v.) total dose of pembrolizumab immunotherapy can be administered. Patients will only be enrolled once the Modi-1 Moditope® expansion doses and a lack of increased anti-CCP antibodies (with, and without, concomitant pembrolizumab) have been established.\n   * HGSOC including fallopian tube and primary peritoneal cancers:\n\n     * patient must be considered unsuitable for platinum chemotherapy, defined as recurrence\u002Fprogression within 6 months of prior platinum-containing chemotherapy or patients in whom platinum therapy is no longer thought appropriate. Patient must have received no more than two non-platinum regimens, from the time the patient is considered unsuitable for platinum chemotherapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing a course of systemic therapy for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n   * RCC:\n\n     * patient is untreated for advanced RCC (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has received first-line treatment consisting of anti-angiogenic therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has favourable or intermediate International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) (Modi-1ev\u002FModi-1eKv monotherapy cohort).\n     * patient has intermediate or poor International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk score (Heng et al. 2013) and is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has stopped immunotherapy due to toxicity and with residual disease as measurable by RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient completing immunotherapy, for whom a subsequent SOC therapy is not yet indicated or appropriate and with measurable disease in accordance with RECIST 1.1 (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient on active surveillance (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n     * patient is eligible for SOC nivolumab with ipilimumab immunotherapy (Modi-1ev\u002FModi-1eKv + CPI doublet cohort only).\n     * patient has refused SOC therapy (Modi-1ev\u002FModi-1eKv monotherapy cohort only).\n3. Where applicable, patient has completed last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment.\n4. Patient has been fully vaccinated against COVID-19, the last vaccination being at least 14 days prior to the patient's first dose of IMP, except for those who have declined or are not eligible for COVID-19 vaccination.\n5. Patient has recovered to Grade ≤1 (CTCAE v5.0) from the effects (excluding alopecia) of any prior therapy for their malignancies.\n6. Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI) (non-neoadjuvant cohorts).\n7. Wherever possible, patients not scheduled for curative intent resection surgery should have a fresh tumour biopsy (or have an archival biopsy \\[obtained within the past 5 years\\] if obtaining a fresh biopsy is not feasible) at baseline for molecular studies, and agree to a post-treatment biopsy (at Week 25 or one of the EOT visits), if feasible. Patients in the SCCHN neoadjuvant cohort must have both a fresh pre-treatment biopsy and agree to have their resected tumour analysed.\n8. Patient is male or female and at least 18 years of age.\n9. Patient has a life expectancy of more than 6 months.\n10. Patient has an ECOG performance status of 0 or 1.\n11. Patient has adequate organ function as determined by the following laboratory values: absolute neutrophil count ≥1.5 x 109\u002FL, platelets ≥100 x 109\u002FL, haemoglobin \\>90 g\u002FL (\\>5.6 mmol\u002FL), lymphocytes ≥ 1 x 109\u002FL, serum creatinine ≤1.5 x upper limit of the normal range (ULN), serum total bilirubin ≤1.5 x ULN, serum transaminases (aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\]) ≤2.5 x ULN or ≤5.0 x ULN if liver metastases present.\n12. Patient must be able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed).\n13. Women of child-bearing potential must have a negative serum pregnancy test during Screening (and a urine test within the 7 days prior to Day 1) and be neither breastfeeding nor intending to become pregnant during study participation. Women of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the Summary of Product Characteristics \\[SmPC\\] of the CPI requires it).\n14. Men who are potentially fertile with partners of child-bearing potential must agree to use highly effective contraceptive methods for the duration of study participation, and for 120 days after discontinuation of vaccine monotherapy or 5 months after use with a CPI (or longer if the SmPC of the CPI requires it).\n15. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n16. Patient scheduled to receive a CPI (e.g., pembrolizumab alone or nivolumab alone or where applicable with ipilimumab) together with Modi-1ev\u002FModi-1eKv must have been clinically evaluated, have not received prior CPI therapy, and the CPI must be deemed an appropriate treatment for their disease according to the CPI's SmPC (this does not apply to the neoadjuvant SCCHN cohort).\n\nEXCLUSION CRITERIA\n\n1. Patient has symptomatic central nervous system metastases or carcinomatous meningitis.\n2. Patient is taking any systemic steroid therapy (exceeding 10 mg\u002Fday of prednisolone or equivalent) or is on any other form of immune suppressant medication within 2 weeks prior to the first dose of IMP. Physiological doses of systemic steroids such as those for the management of adrenal insufficiency, topical and inhaled steroids, such as those for the management of asthma, and patients with hypothyroidism stable on hormone replacement, are permitted.\n3. Patient has a history of malignancy other than the disease under study within 2 years prior to Screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 2-year overall survival rate \\>90%), such as adequately treated carcinoma-in-situ of the breast or the cervix, melanoma-in-situ, non-melanoma skin carcinoma, superficial bladder cancer, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range or stage I endometrial cancer.\n4. Patient is pregnant, lactating, or is expecting to conceive\u002Ffather children within the duration of the study.\n5. Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to, uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, uncontrolled diabetes mellitus, pulmonary disease (including obstructive pulmonary disease and pulmonary fibrosis), alcoholic liver disease, or primary biliary cirrhosis.\n6. Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction or stroke within previous 6 months, a history of significant cardiac abnormality and\u002For significant abnormal baseline ECG readout, active ischaemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy, uncontrolled hypertension, significant cerebrovascular disease, or congestive heart failure.\n7. Patient has anti-CCP antibody levels classified as equivocal or positive according to NHS guidelines, i.e., ≥ the ULN, or has an active autoimmune disease that may impact on the study treatment in the opinion of the Investigator.\n8. Patient has received a live vaccine within 28 days, or an influenza vaccine within 14 days prior to the first dose of IMP. The timing of any other vaccines should be assessed on a case-by-case basis by the Investigator prior to study enrolment.\n9. Patient has a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV; surface antigen reactive) or hepatitis C (HCV; RNA detected).\n10. COVID-19 vaccination within 14 days prior to the first dose of IMP.\n11. Patient has a known current or recent history (within the last year) of substance abuse including illicit drugs or alcohol.\n12. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis \\[SJS\u002FTEN\\], or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\]), or dose-limiting immune-mediated reactions (Modi-1ev\u002FModi-1eKv + CPI RCC cohort only).\n13. Patient has a known hypersensitivity to the IMP under study or their excipients. Where SOC CPIs are planned to be given with the IMP, the patient must not have a known hypersensitivity to the CPIs or their excipients.",{"count":221,"type":21},168,[24,25],"The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced\u002Funresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC).\n\nModi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.",[225,29,226,227],"Triple Negative Breast Cancer","High Grade Ovarian Serous Adenocarcinoma","Squamous Cell Carcinoma of the Head and Neck",[229,230,231],"vaccine","peptide","Phase II","2025-09-11",{"date":234,"type":42},"2025-09-17",{"date":236,"type":42},"2022-04-07",{"date":238,"type":21},"2027-07-01",{"name":240,"class":92},"Scancell Ltd",16,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":258,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":50},"100585511","phase-4-primary-tumor-ablation-and-outcome-in-metastatic-renal-cell-carcinoma-treated-with-immunotherapy-combinations-100585511","NCT06903312","Primary Tumor Ablation and Outcome in Metastatic Renal Cell Carcinoma Treated With Immunotherapy Combinations.","Clinical and Humoral Impact of Primary Tumor Ablation in Metastatic Renal Cell Carcinoma Treated With Immunotherapy. The ITALIC-RCC Randomized Study.","ITALIC-RCC","Inclusion Criteria:\n\n1. Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.\n2. Male or female patient ≥18 years of age.\n3. Histological or cytological documentation of renal cell carcinoma with predominantly clear cell histology.\n4. Evidence of primary renal cancer.\n5. Measurable or not measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1 \\[22\\].\n6. Eastern Cooperative Oncology Group performance status of ≤1.\n7. Life expectancy of at least 9 months.\n8. Under treatment with one anti-PD1 based therapy (SOC) among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab for at least 24 but not more than 52 weeks at the time of the signed informed consent and without evidence of progressive disease based on RECIST criteria v 1.1 \\[21\\].\n9. Eligible to continue the combination of therapies for mRCC (or nivolumab alone in case of nivolumab + ipilimumab).\n10. Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.\n11. Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:\n\n    1. Creatinine value \\\u003C2.5 mg\u002Fdl and creatinine clearance \\> 30 ml\u002Fmin evaluated by the Cockcroft-Gault Formula.\n    2. Total bilirubin ≤1∙5 × the upper limit of normal (ULN);\n    3. Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer);\n    4. International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care;\n    5. Platelet count ≥100 000\u002Fmm3, hemoglobin \\>9 g\u002Fdl, absolute neutrophil count \\>1,500\u002Fmm3;\n    6. Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).\n\nExclusion Criteria:\n\n1. More than one treatment for metastatic or locally advanced renal cell carcinoma.\n2. Solitary kidney\n3. Any contraindication to surgery or radiotherapy on primary renal tumor.\n4. Discontinuation (definitive) of one of the therapies for mRCC due to toxicity (previous discontinuation of ipilimumab in the ipilimumab + nivolumab combo is allowed).\n5. Concurrent or previous cancer within 3 years before enrolment EXCEPT curatively treated cervical cancer in situ, non-melanoma skin cancer and pT2 prostate cancer with PSA\\\u003C0.01 or non-muscle invasive bladder cancer.\n6. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before the signed informed consent.\n7. Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before surgery or radiotherapy on primary tumor, and a negative result must be documented before start of treatment.\n8. Any cardiological condition among:\n\n   1. Congestive heart failure of New York Heart Association class 3 or worse.\n   2. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug.\n   3. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).\n   4. Uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic pressure \\>90 mmHg despite optimal medical management).\n   5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism within the 4 months before start of study.\n9. Ongoing infection higher than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 grade 2.\n10. Known history of human immunodeficiency (HIV) virus infection or known history of chronic hepatitis B or C.\n11. Any autoimmune reaction or toxicity that contraindicates the use of anti-PD1 therapy.\n12. Seizure disorder requiring medication.\n13. Symptomatic metastatic brain or meningeal tumors unless the patient is \\>2 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also, the patient must not be undergoing acute steroid therapy or tapering (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before and after screening radiographic studies).\n14. History of organ allograft.\n15. Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event of CTCAE grade 3 or higher within 4 weeks of start of study medication.\n16. Non-healing wound, ulcer, or bone fracture.\n17. Renal failure requiring hemodialysis or peritoneal dialysis.\n18. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.",{"count":251,"type":21},409,[192],"This is Phase IV, randomized, multi arm, multicenter, low interventional clinical trial, aiming to evaluate if treatment of primary tumor in mRCC patients with initial benefit to anti-PD1- based therapy (SOC) can improve the overall survival.\n\nAll patients eligible according to inclusion and exclusion criteria will be enrolled and randomized to different treatment options based on tumor extension of the primary kidney cancer.\n\nThose with primary kidney cancer ≤ 4 cm will be randomized 1:1:1 to receive:\n\n* Cytoreductive Nephrectomy + standard of care (SOC) or\n* RT on primary tumor + SOC or SOC alone.\n\nThose with primary kidney cancer \\> 4 cm will be randomized 1:1 to receive:\n\n• Deferred Cytoreductive Nephrectomy + SOC or SOC alone. Patients randomized to Deferred Cytoreductive Nephrectomy can be treated with one among radical nephrectomy; partial nephrectomy or lumpectomy.\n\nPatients randomized to RT should be treated with single shot of 25 Gy (or with multiple fractions with equivalent biological dose).\n\nThe SOC medical therapy is the continuation of the combination of medical therapy for mRCC including one of the available combination among axitinib + pembrolizumab or cabozantinib + nivolumab or lenvatinib + pembrolizumab or nivolumab alone after nivolumab + ipilimumab.",[29,255,37,73,256,257],"Kidney Neoplasm","Surgery Programmed","Radiotherapy",[259,260,261,262,263],"renal cancer","primary tumor","cytoreductive nephrectomy","immunothreapy","radiotherapy","2025-06-30",{"date":266,"type":42},"2025-07-03",{"date":268,"type":42},"2025-06-15",{"date":270,"type":21},"2028-04-01",{"name":272,"class":142},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":299},"100594494","using-3d-kidney-model-based-on-artificial-intelligence-to-assist-partial-nephrectomy-a-prospective-validation-study-100594494","NCT07020169","Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study","Artificial Intelligence-Driven 3D Kidney Model for Real-Time Augmented Reality and Surgical Navigation in Minimally Invasive (Robotic\u002FLaparoscopic) Partial Nephrectomy: A Prospective Validation Study","Inclusion Criteria:\n\n* Ages 18-80 years, regardless of gender\n* Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure\n* Preoperative imaging (CT\u002FMRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)\n* Localized renal tumors without lymph node\u002Fdistant metastasis per NCCN Guidelines® (v2023)\n* Elective minimally invasive partial nephrectomy (laparoscopic\u002Frobotic) after comprehensive surgical counseling\n\nExclusion Criteria:\n\n* Multifocal renal tumors (bilateral or unilateral)\n* Prior systemic anticancer therapy (targeted agents\u002Fimmunotherapy\u002Fchemotherapy) within 6 months\n* Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)\n* Intraoperative conversion to radical nephrectomy or open approach\n* Postoperative adjuvant therapy during protocol-defined follow-up (12 months)\n* Major comorbidities (e.g., NYHA class III\u002FIV heart failure, eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) affecting outcome assessment\n* Concurrent enrollment in interventional clinical trials\n* Investigator-determined ineligibility based on risk-benefit analysis",{"count":281,"type":21},232,[283],"NA","The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy:\n\n• Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?",[29],[287,288,289],"partial nephrectomy","Articicial Intelligence","Intraoperative Real-Time Navigation","2025-06-12",{"date":292,"type":42},"2025-06-13",{"date":294,"type":42},"2025-05-01",{"date":296,"type":21},"2027-03-01",{"name":298,"class":142},"Shao Pengfei",2,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":307,"targetDuration":309,"studyType":128,"phases":4,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":299},"100573839","the-value-of-a-convolutional-neural-network-based-renal-artery-perfusion-model-in-predicting-renal-function-after-partial-nephrectomy-a-prospective-study-100573839","NCT06751498","The Value of a Convolutional Neural Network-Based Renal Artery Perfusion Model in Predicting Renal Function After Partial Nephrectomy: A Prospective Study","The Value of a Renal Artery Perfusion Model Based on Convolutional Neural Network in Predicting Renal Function After Partial Nephrectomy: A Prospective, Single-Center Study","Inclusion Criteria:\n\n* people with stage cT1 renal tumors confirmed by preoperative CT or MR\n* people who are proposed to undergoing partial nephrectomy\n* localized renal tumors without lymph node and distant metastases as defined by NCCN guidelines\n* ECOG score of 0 or 1\n* Life expectancy greater than 10 years\n\nExclusion Criteria:\n\n* people with surgically unresectable lesions\n* people with Abnormal preoperative renal function, eGFR(estimated by CKD-EPI)\\\u003C90ml\u002Fmin\u002F1.73m2\n* people who receive preoperative molecular targeted therapy, immunotherapy, chemotherapy\n* people with any contraindications to surgery\n* people who convert to radical nephrectomy during surgery\n* people who receive molecular targeted therapy, immunotherapy or chemotherapy during the postoperative follow-up period\n* people with serious systemic disease",{"count":308,"type":21},300,"1 Year","The goal of this observational study is to develop a CNN-based machine module to predict postoperative fractional renal function in people who are proposed to undergo partial nephrectomy. The main question it aims to answer is:\n\n• Does this machine learning model accurately predict renal function after partial nephrectomy?",[29],[288,313,314,287,315],"convolutional neural network","renal arterial perfusion model","fractional renal function","2025-04-14",{"date":318,"type":42},"2025-04-17",{"date":320,"type":42},"2025-01-01",{"date":322,"type":21},"2028-01-01",{"name":298,"class":142},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":341,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100436903","phase-1-tt-10-port-6-and-tt-4-port-7-as-single-agents-and-in-combination-in-subjects-with-advanced-selected-solid-tumors-100436903","NCT04969315","TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors","Phase I\u002FII First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors","ADPORT-601","To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria:\n\n1. Participants must be ≥18 years of age.\n2. Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of any study-specific procedures.\n3. Diagnosis of histologically or cytologically confirmed advanced selected solid tumors:\n\n   Cohort A - TT-10 dose escalation:\n   1. RCC: Participants with locally advanced or metastatic RCC that have previously received at least two prior systemic regimens, including vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy\n   2. CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy.\n   3. SCCHN: Participants with advanced or metastatic SCCHN that is incurable by surgery or radiotherapy and that has progressed during or after a platinum-based chemotherapy and\u002For checkpoint inhibitor therapy (separately or in combination)\n   4. NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n\n   Cohort B - TT-4 dose escalation:\n   1. CRC: Participants with metastatic CRC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   2. CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated) and a taxane-based chemotherapy\n   3. NSCLC: Participants with metastatic NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   4. Endometrial cancer: Participants with metastatic endometrial cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available\n   5. Ovarian cancer: Participants with metastatic ovarian cancer that is intolerant or resistant to standard therapy or for which no standard therapy is available\n\n   Cohort C- TT-10 + TT- 4 dose escalation and expansion:\n\n   a. The tumor types will include 1 or more of those enrolled in the respective Escalation Cohorts (A and B), and will be determined following review of the dose escalation data by the SMC.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 - 1\n5. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n   a. Participants with CRPC who have metastatic disease that is non-measurable are eligible if screening PSA ≥ 2.0 ng\u002FmL and with Sponsor approval\n6. Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the investigator)\n7. Consent to baseline biopsy, with the following exceptions:\n\n   1. Participants whose only site(s) of disease are in areas considered moderate or high risk may be enrolled without a fresh biopsy with Sponsor approval;\n   2. Archival tissue may be submitted in lieu of a fresh biopsy if collected within 6 months of screening and without intervening systemic therapy.\n8. Participants must have adequate hematologic function based on the following:\n\n   * ANC ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9.0 g\u002FdL\n9. Participants must have adequate hepatic function based on the following:\n\n   * Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome)\n   * ALT\u002FAST ≤ 2.5 x ULN (≤ 5 x ULN for participants with known hepatic metastases)\n10. Participants must have adequate renal function based on the following:\n\n    * Serum creatinine ≤ 1.5 x ULN; or\n    * Serum creatinine clearance ≥ 60 mL\u002Fmin, as determined by Cockcroft-Gault equation\n11. For women of childbearing potential (WCBP): negative urine pregnancy test (UPT) within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women \\> 55 years of age). WCBP should be placed on effective birth control directly after testing negative for pregnancy; if not, then WCBP should have a UPT on Day 1 of every cycle, prior to study intervention administration. Any positive or indeterminant UPT result must be confirmed by serum.\n\n    a. Female participants of childbearing potential must use a highly effective mode of contraception or abstain from heterosexual activity for the duration of the study and for 120 days following the last dose of study intervention. A female is NOT of childbearing potential if she has undergone bilateral salpingoophorectomy or is menopausal, defined as an absence of menses for 12 consecutive months. Male participants must agree to use highly effective contraception.\n12. Ability to adhere to the study visit schedule and all protocol requirements\n13. Must be able to swallow capsules\n\nParticipants will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:\n\nParticipants are to be excluded from the study if they meet any of the following criteria:\n\n1. Major surgery within 4 weeks prior to Screening\n2. Participants with active CNS metastases; however, participants who have undergone radiation and\u002For surgery for the treatment of CNS metastases, who are neurologically stable and who are no longer taking pharmacologic doses of corticosteroids are eligible; participants with leptomeningeal metastases are not eligible.\n3. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n4. Prior anti-cancer therapy within 4 weeks prior to the start of study intervention. A 2 week washout is acceptable for short-acting drugs (eg, tyrosine kinase inhibitors). Any treatment-related toxicities must be resolved to Grade 0 - 1.\n5. Human immunodeficiency virus (HIV)-infected participants\n6. Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment.\n\n   Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n   Hepatitis B screening tests are not required unless:\n   * Known history of HBV infection\n   * As mandated by local health authority\n7. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to enrollment.\n\n   Hepatitis C screening tests are not required unless:\n   * Known history of HCV infection\n   * As mandated by local health authority\n8. Participants who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥ 10 mg prednisone daily), cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc. or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency)\n9. Participants requiring administration of drugs known to be strong inhibitors or inducers of CYP3A4, 2C9 or 2C19\n10. Participants requiring drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids, such as calcium carbonate or aluminum hydroxide-based products, will be allowed during the study, but are recommended to be taken either 4 hours before or 2 hours after dosing of TT 10 (PORT 6) or PORT-7.\n11. Ongoing systemic bacterial, fungal or viral infections at Screening\n\n    a. NOTE: Participants on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion\u002Fexclusion criteria are met\n12. Administration of a live vaccine within 6 weeks of first dose of study intervention. Messenger ribonucleic acid (mRNA) vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) infection are permitted.\n13. Baseline QT interval corrected with Fridericia's method (QTcF) \\> 470 ms (average of triplicate readings)\n\n    a. NOTE: Criterion does not apply to participants with a right or left bundle branch block.\n14. Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)\n15. Female participants who are pregnant or breastfeeding\n16. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix or prostate intraepithelial neoplasia\n17. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n18. History of peptic ulcer and\u002For gastrointestinal bleed within the past 6 months prior to Screening\n19. History of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening\n20. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and\u002For interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the participant associated with his or her participation in the study",{"count":333,"type":21},90,[24,25],"The goal of this clinical trial is to evaluate TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in participants with advanced selected solid tumors, who have failed or are not eligible for standard of care. The main questions it aims to answer are:\n\n1. To evaluate the safety and tolerability of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade)\n2. To determine the maximum tolerated dose or the recommended phase 2 dose of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade)\n3. To obtain a preliminary estimate of efficacy of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in advanced solid tumors.",[29,337,75,338,339,340,32],"Castrate Resistant Prostate Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Cancer (CRC)","Endometrial Cancer",[342,343,344,345,346,347,348,349,330,350,351,352,353,354,355],"Failed or not eligible for standard of care","Advanced Selected Solid Tumors","TT-10","Adenosine","Adenosine Antagonist","A2A","A2AR Inhibitor","PORT-6","TT-4","PORT-7","A2B","Dual","A2AR","A2BR","2025-03-28",{"date":358,"type":42},"2025-04-02",{"date":360,"type":42},"2023-06-23",{"date":362,"type":21},"2027-12-31",{"name":364,"class":92},"Portage Biotech",3,{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":373,"targetDuration":375,"studyType":128,"phases":4,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":392,"locationsCount":50},"100571028","optimising-renal-tumour-management-through-artificial-intelligence-modules-100571028","NCT06714916","Optimising Renal Tumour Management Through Artificial Intelligence Modules","Mutimodal Artificial Intelligence for Optimising Renal Tumour Management: Diagnosis, Surgery and Prognosis","Inclusion Criteria:\n\n* Patients with renal tumor which can be treated by surgery;\n* Complete CECT within 30 days before surgery;\n* Patients who fully understand this study and sign the informed consent;\n\nExclusion Criteria:\n\n* Patients with any item missing from the baseline clinical and pathological information;\n* Patients who has already metastasized by the time the tumor is discovered;\n* Previous treatment in any form, including surgery, targeted therapy and immunotherapy;",{"count":374,"type":21},2100,"5 Years","The goal of this observational study is to improve the management of people with renal tumour by multimodal artificial intelligence(AI). It will also measure the accuracy of the predictions from AI models. The main questions it aims to answer are:\n\n1. whether the AI module can accurately provide tumor-related information such as Benign or malignant, subtypes, grading, stage, etc. by learning from preoperative CT images.\n2. whether the AI module can help clinicians find out the most suitable surgical programme for people with renal tumor.\n3. whether the AI module can integrate CT images and pathology slides, offering supplementary prognostic information to improve postoperative survival.\n\nParticipants who complete a CT(usually Contrast-enhanced CT, CECT) examination and undergo radical or partial nephrectomy will carry out active surveillance and record postoperative survival data for 5 years.",[378,379,29],"Renal Neoplasms","Pathology",[288,381,382,383,384,385],"Renal tumors","Prediction Model","Surgery","Radiomics","Pathomics","2025-03-16",{"date":388,"type":42},"2025-03-19",{"date":320,"type":42},{"date":391,"type":21},"2033-12-31",{"name":298,"class":142},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":401,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":412,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":50},"100573386","prehabilitation-prior-to-surgery-for-kidney-tumors-100573386","NCT06745609","Prehabilitation Prior to Surgery for Kidney Tumors","Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)","Pre-KiT","Inclusion Criteria:\n\n* 65 years or older\n* cT1 kidney tumor, scheduled for either partial or radical nephrectomy.\n* Clinical Frailty Scale 3-6\n\nExclusion Criteria:\n\n* It is determined by an attending physician, or at a multi-disciplinary team-conference, that a 2-4 week postponement of surgery will not be beneficial for the participant.\n* Participant does not understand Danish og English","65 Years",{"count":403,"type":21},60,[283],"The goal of this clinical trial is to examine if one month of general health optimization before surgery for kidney tumors can help participants recover more quickly from surgery.\n\nThe optimization process is called prehabiliation, and will last one month. It consists of\n\n1. A comprehensive health assessment\n2. Assisted smoking cessation\n3. A home exercise program.\n\nThe investigators will compare an intervention group receiving one month of prehabilitation with a control group receiving the standard of care.\n\nSome of the main questions the investigators want to answer are\n\n* Are participants in the intervention group more satisfied with their quality of recovery after surgery?\n* Do participants in the intervention group maintain more of their physical abilites compared to the control group?",[407,29,408,409,410,411],"Renal Cancer","Kidney Cancers","Stage I Renal Cell Cancer","Prehabilitation","Elderly (People Aged 65 or More)",[410,413,414,415,416,417,418,419],"Quality of life","Kidney tumor","Renal cell tumor","Renal cell cancer","Kidney cancer","Quality of recovery","Elderly","2025-01-22",{"date":422,"type":42},"2025-01-24",{"date":424,"type":42},"2025-01-21",{"date":426,"type":21},"2032-03",{"name":428,"class":142},"Herlev and Gentofte Hospital",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":435,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":4},"100575522","study-of-the-prognostic-impact-of-cd44-on-renal-cell-carcinoma-100575522","NCT06773377","Study of the Prognostic Impact of CD44 on Renal Cell Carcinoma","Inclusion Criteria:\n\n* patient must be more than 18 years\n* Patients with complete pathological data\n\nExclusion Criteria:\n\n* The presence of any other organ malignancies\n* Patients who lost follow-up after nephrectomy less than 3-year,\n* Patients with incomplete pathological data",{"count":436,"type":21},77,"1. Study the expression of CD44 in various histopathological types of RCC.\n2. Study the association between CD44 expression and other clinicopathological parameters\n3. study the impact of CD44 expressions in tumor and patients' survival",[29],"2025-01-09",{"date":441,"type":42},"2025-01-14",{"date":443,"type":21},"2025-11-01",{"date":445,"type":21},"2026-12-01",{"name":447,"class":142},"Assiut University",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100537734","phase-2-a-study-of-ibi363-in-subjects-with-advanced-solid-malignancies-100537734","NCT06281678","A Study of IBI363 in Subjects with Advanced Solid Malignancies","A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Male or female subjects ≥ 18 years old;\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n4. Anticipated life expectancy of ≥ 3 months;\n\nExclusion Criteria:\n\n1. Inadequate bone marrow and organ function;\n2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose\n3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;\n4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;\n5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.",{"count":456,"type":21},178,[25],"This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.",[31,460,70,29],"Non-small Cell Lung Cancer","2024-12-16",{"date":463,"type":42},"2024-12-19",{"date":465,"type":42},"2024-04-08",{"date":467,"type":21},"2026-12-31",{"name":469,"class":92},"Innovent Biologics (Suzhou) Co. Ltd.",9,{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":16,"minAge":477,"maxAge":4,"enrollmentInfo":478,"targetDuration":480,"studyType":128,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":50},"100410518","development-of-urologic-registry-for-personalized-medicine-in-patients-with-urologic-malignant-diseases-by-analyzing-microbiome-100410518","NCT04625556","Development of Urologic Registry for Personalized Medicine in Patients With Urologic Malignant Diseases by Analyzing Microbiome","Inclusion Criteria:\n\n* Patients diagnosed as urological malignancies (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)\n* Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2020.10 and 2030.10\n* Those who agree to give permission to use their human source information\n* Those who agree with this study\n\nExclusion Criteria:\n\n* Those who do not agree with this study\n* Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making","20 Years",{"count":479,"type":21},3000,"10 Years","Genitourinary malignancies such as prostate cancer, renal cell cancer, and bladder cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of technologies, studies have found that microbiome not only affects human physiological functions, such as metabolism, immunity, and haematopoiesis, but also plays a significant role in the development and progression of malignancies. However, the investigation of microbiome in urological malignances have been limited and few studies have been reported. Therefore, the investigator tried to evaluate the usefulness of microbiome in detection and monitoring of urological malignancies in Korean population. This study aims to use microbiome in tissue, plasma, stool and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for microbiome of urological malignancies in Korean population.",[483,484,29,485,486],"Urological Malignancies","Prostate Cancer","Bladder Cancer","Ureter Cancer","2023-01-30",{"date":489,"type":42},"2023-01-31",{"date":491,"type":42},"2022-12-19",{"date":493,"type":21},"2030-10",{"name":495,"class":142},"Yonsei University",{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":477,"maxAge":4,"enrollmentInfo":502,"targetDuration":480,"studyType":128,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":50},"100377660","development-of-urologic-registry-for-personalized-medicine-in-patients-with-urological-malignancy-by-analyzing-circulating-tumor-dna-100377660","NCT04197414","Development of Urologic Registry for Personalized Medicine in Patients With Urological Malignancy by Analyzing Circulating Tumor DNA","Inclusion Criteria:\n\n* 1\\. Patients diagnosed as urological malignances (prostate cancer, renal cell cancer, bladder cancer, and ureter cancer)\n* 2\\. Patients who have undergone surgeries due to urological malignancies in Severance Hospital, Sinchon from 2019.12 and 2029.11\n* 3\\. Those who agree to give permission to use their human source information - 4. Those who agree with this study\n\nExclusion Criteria:\n\n* 1\\. Those who do not agree with this study\n* 2\\. Vulnerable participants who are likely to be vulnerable to coercion or undue influence or lack decision-making",{"count":479,"type":21},"Urological malignancies such as prostate cancer and renal cell cancer in Korean population have been increased due to the aged population and the westernized lifestyles. With the advancement of sequencing technologies, use of genetic mutation profiles in cancer detection and progression has been increased. However, use of circulating tumor DNA in urological malignances have been limited and few studies have been reported. Therefore, we tried to evaluate the usefulness of circulating tumor DNA in detection and monitoring of urological malignancies in Korean population. This study aims to use circulating tumor DNA in plasma and urine for the diagnosis, disease progression monitoring and therapeutic response evaluation. This study plan includes building big databases for circulating tumor DNA of urological malignancies in Korean population and to develop optimized circulating tumor DNA platform.",[484,29,485,486],"2019-12-10",{"date":507,"type":42},"2019-12-13",{"date":509,"type":42},"2019-12-06",{"date":511,"type":21},"2029-12",{"name":495,"class":142}]